FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
50090-5968
11-digit product format
500905968
Labeler code
50090
Product ID
50090-5968_f8b56135-aaa3-4dc0-8f86-3f23e299ba7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ipratropium bromide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
A-S Medication Solutions
Application
ANDA076155
Marketing category
ANDA
Marketing start
2020-05-26
Substance
IPRATROPIUM BROMIDE
Active strength
42 ug/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076155-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.042MG/SPRAYSPRAY, METERED / NASALAB2003-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076155-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076155-001IPRATROPIUM BROMIDE0.042MG/SPRAYSPRAY, METERED / NASALAB2003-04-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076155-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDENORTHSTAR RX LLCe592b6b5-038a-dbe8-457e-76e88a0f194a2026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076155
application number: ANDA076155
Ipratropium BromideIPRATROPIUM BROMIDEApotex Corp.ec4c8c83-0335-544c-271e-4f27c06105ac2025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076155
application number: ANDA076155
Ipratropium BromideIPRATROPIUM BROMIDEA-S Medication Solutions411ccc2c-ec30-450d-8704-b63095fd343b2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076155
application number: ANDA076155
ndc (product): 50090-5968

Additional Listing Data#

Finished product
Yes
Brand name base
Ipratropium Bromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IPRATROPIUM BROMIDE42 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J697UZ2A9JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1797844Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
411ccc2c-ec30-450d-8704-b63095fd343bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36cProduct name220251106
d953267a-4ca0-4d44-91ad-712cdee8ab38Product name220250630
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5968-0Ipratropium Bromide165 in 1 BOTTLE, PUMPSPRAY, METERED1655
50090-5968-0Ipratropium Bromide1 in 1 CARTONSPRAY, METERED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5968-0ML - Milliliter50090-59686f1ed1b2-9602-4715-af27-4659c947aeb912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5968IPRATROPIUM BROMIDE SPRAY, METERED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20250124_411ccc2c-ec30-450d-8704-b63095fd343b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797844ipratropium Br 42 MCG/ACTUAT (0.06 % ) Metered Dose Nasal SprayPSN411ccc2c-ec30-450d-8704-b63095fd343b5
1797844ipratropium bromide 0.042 MG/ACTUAT Metered Dose Nasal SpraySCD411ccc2c-ec30-450d-8704-b63095fd343b5
1797844ipratropium bromide 0.06 % Metered Dose Nasal SpraySY411ccc2c-ec30-450d-8704-b63095fd343b5
1797844ipratropium bromide 42 MCG/ACTUAT Metered Dose Nasal SpraySY411ccc2c-ec30-450d-8704-b63095fd343b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5968-0500905968001 BOTTLE, PUMP in 1 CARTON (50090-5968-0) / 165 SPRAY, METERED in 1 BOTTLE, PUMP2022-04-280000-00-00NoNoCurrent